AgitationPhase 4NCT05273671
Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics
A Phase 4 study testing Nalbuphine, Dexmedetomidine and normal Saline in people with Agitation, run by Alexandria University at 1 site in Egypt.
Trial summary
the investigators hypothesized that Nalbuphine may be alternative pharmacological agent for prevention of emergence agitation in pediatrics who will be scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) during sevoflurane anesthesia Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Agitation
- What is being tested?
- Nalbuphine, Dexmedetomidine and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 2 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I \&II
- scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) under general anesthesia
Who cannot join
- history of hypersensitivity to the studied drug,
- refusal of the legal guardian
- chronic or acute intake of any sedative or analgesic drugs,
- Psychological\& emotional disorder.
- Cognitive or developmental disorders.
- severely agitated child at induction of anesthesia
Show all 9Show fewer
- Any neurological condition that would limit the patient's ability to communicate with or understand nursing personnel,
- Existing contraindications to caudal block such as coagulopathy, local and systemic infection.
- Failure of the caudal block.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, 0203
Mohamed M osman, 01006357996, yasseralx@hotmail.com
Yasser m osman, assist prof
About this study
Official title: Comparison Between Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics During Sevoflurane Anesthesia: Prospective Randomized Controlled Clinical Trial
the investigators hypothesized that Nalbuphine may be alternative pharmacological agent for prevention of emergence agitation in pediatrics who will be scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) during sevoflurane anesthesia
Read the detailed description
SEVOFLURANE is widely used popular inhalational anesthetic to induce and maintain anesthesia in children due to its greater hemodynamic stability, less irritation of the airway and low blood gas solubility coefficient, which causes rapid emergence and recovery from general anesthesia in pediatric anesthesia. [1] However, sevoflurane anesthesia is frequently associated with emergence agitation (EA) in children with incidence ranging up to 80%. [2-5] EA is a complex phenomenon and a variety of explanations have been proposed for its etiology. These include multiple surgical and patient related factors as well as anesthesia related factors such as rapid emergence due to the low blood solubility of sevoflurane.[1,2,6] Despite it is usually self limited; EA is still a considerable side-effect because of the risks of falling, self-injury to the child or to the surgical site, the stress caused to both caregivers and families, moreover, increase the need for continuous monitoring of patients by recovery room staffs and physical restraint of patient.[6] Several medications like propofol, fentanyl, a2-adrenergic receptor agonist and ketamine have been investigated in an attempt to reduce the occurrence and severity of EA, with variable outcomes. [4-11] Dexmedetomidine is an a-2 adrenergic agonist with a larger ratio of a2/a1 activity (1600:1) when compared to clonidine (200:1).The hemodynamic effects of dexmedetomidine are similar to that of clonidine and the effects can vary depending on the dose, rat. [10] Nalbuphine (NAL) is a synthetic opioid agonist antagonist acts on kappa and mu opioid receptor producing analgesia and sedation .One of the advantages of NAL over pure narcotic agonists is inducing minimal respiratory depression, it is considered a safe drug and the large margin of safety make it often used for pediatric patients. It has been shown that the use of nalbuphine carries a lower risk of adverse events like nausea, vomiting, pruritus, constipation, and respiratory depression Our primary outcome: The incidence of post-operative EA Secondary outcome:Time to emergence in minutes Time to extubation in minutes Children's hospital eastern Ontario pain scale. Discharge time (min) The time of first postoperative analgesic dose Possible postoperative side effects. All patients will undergo thorough preoperative evaluation, which include history, physical examination and relevant laboratory investigations. None of the patients will be given any solid food for 6 hours preoperatively but each will be encouraged to take clear fluids until 2 hours before induction of anesthesia. All patients will be pre-medicated with 0.3 mg/kg oral midazolam (maximum dose of 12 mg) 30 min before induction. Upon arrival at the operating room, patients will be monitored by non-invasive the blood pressure, temperature, electrocardiogram capnography and pulse oximetry.
Inhalation induction will be done via transparent face mask after saturating the breathing system (Jackson-Rees modification of Ayer's T-piece) with a mixture of sevoflurane 8 vol % in 100% O2 (6 L/min). After loss of consciousness, intravenous line will be inserted and Rocuronium 0.6 mg/kg is administered and when adequate depth of anesthesia is reached, a laryngeal mask airway (LMA) of appropriate size for the age and weight of the child will be placed .Anesthesia will maintained with sevoflurane at 2 3 vol % in 40% O2 in air to maintain a stable heart rate, blood pressure and respiratory rate (base line ± 20%). Paracetamol 15 mg/kg (Perfalgan® 100 ml vial UPSA France) and Dexamethasone 0.3 mg/kg will be administered IV to each child immediately after the induction of anesthesia. Lung ventilation will be controlled to maintain the end tidal carbon dioxide tension between 30 and 35 mmHg. Caudal block with 1.0 ml/kg 0.25% bupivacaine will be performed in all patients. Failure of caudal block will be defined as increase in heart rate and or mean arterial blood pressure (MAP) > 10% than pre-incisional value at the start of surgery. No opioid will be given; no propofol will be used during the procedure.
The allocated children will be randomly assigned through computer-generated random numbers contained in sealed opaque envelopes to one of the three groups:
- Conditions
- Agitation
- Being tested
- Nalbuphine, Dexmedetomidine, normal Saline
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Also called nalophen
will receive 0.1 mg/kg NAL diluted in 10 ml I.V 10 minutes before the end of surgery
DexmedetomidineDrug
Also called Precedex
will receive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery
normal SalineDrug
Also called saline
will receive with a saline solution 10 min before the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| nalbuphine | Experimental | 0.1 mg/kg nalbuphine diluted in 10 ml I.V 10 minutes before the end of surgery Receives: Drug: Nalbuphine |
| dexmedetomedine | Experimental | receive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery Receives: Drug: Dexmedetomidine |
| saline | Placebo comparator | receive a saline solution 10 min before the end of surgery Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) change
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) based on crying, facial expression, verbal statements, position of torso, touching of the wound and movement of legs will be used for post-operative pain assessment
- minimum score: 4 best
- maximum score: 13 worse
Measured: at 5, 10, 20 and 30 minutes post-operatively
pediatric anesthesia emergence delirium (PAED) scale change
pediatric anesthesia emergence delirium (PAED) scale, scale that define the child's behavior in the recovery room
- sleeping (best)
- awake, calm
- irritable, crying
- inconsolable crying (worse)
Measured: at 5, 10, 20 and 30 minutes post-operatively
Secondary outcomes (1)
The time of first postoperative analgesic dose
in minutes
Measured: up to 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion2 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yasser M osman, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273671
- Sponsor's protocol ID
- 0305447
- Status last verified
- Feb 2022
- First submitted
- 19 Feb 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics During Sevoflurane Anesthesia: Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05273671
- Acronym / sponsor ID
- 0305447
- Conditions
- Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 2 Jun 2022 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the investigators hypothesized that Nalbuphine may be alternative pharmacological agent for prevention of emergence agitation in pediatrics who will be scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) during sevoflurane anesthesia
Detailed description
SEVOFLURANE is widely used popular inhalational anesthetic to induce and maintain anesthesia in children due to its greater hemodynamic stability, less irritation of the airway and low blood gas solubility coefficient, which causes rapid emergence and recovery from general anesthesia in pediatric anesthesia. [1] However, sevoflurane anesthesia is frequently associated with emergence agitation (EA) in children with incidence ranging up to 80%. [2-5] EA is a complex phenomenon and a variety of explanations have been proposed for its etiology. These include multiple surgical and patient related factors as well as anesthesia related factors such as rapid emergence due to the low blood solubility of sevoflurane.[1,2,6] Despite it is usually self limited; EA is still a considerable side-effect because of the risks of falling, self-injury to the child or to the surgical site, the stress caused to both caregivers and families, moreover, increase the need for continuous monitoring of patients by recovery room staffs and physical restraint of patient.[6] Several medications like propofol, fentanyl, a2-adrenergic receptor agonist and ketamine have been investigated in an attempt to reduce the occurrence and severity of EA, with variable outcomes. [4-11] Dexmedetomidine is an a-2 adrenergic agonist with a larger ratio of a2/a1 activity (1600:1) when compared to clonidine (200:1).The hemodynamic effects of dexmedetomidine are similar to that of clonidine and the effects can vary depending on the dose, rat. [10] Nalbuphine (NAL) is a synthetic opioid agonist antagonist acts on kappa and mu opioid receptor producing analgesia and sedation .One of the advantages of NAL over pure narcotic agonists is inducing minimal respiratory depression, it is considered a safe drug and the large margin of safety make it often used for pediatric patients. It has been shown that the use of nalbuphine carries a lower risk of adverse events like nausea, vomiting, pruritus, constipation, and respiratory depression Our primary outcome: The incidence of post-operative EA Secondary outcome:Time to emergence in minutes Time to extubation in minutes Children's hospital eastern Ontario pain scale. Discharge time (min) The time of first postoperative analgesic dose Possible postoperative side effects. All patients will undergo thorough preoperative evaluation, which include history, physical examination and relevant laboratory investigations. None of the patients will be given any solid food for 6 hours preoperatively but each will be encouraged to take clear fluids until 2 hours before induction of anesthesia. All patients will be pre-medicated with 0.3 mg/kg oral midazolam (maximum dose of 12 mg) 30 min before induction. Upon arrival at the operating room, patients will be monitored by non-invasive the blood pressure, temperature, electrocardiogram capnography and pulse oximetry.
Inhalation induction will be done via transparent face mask after saturating the breathing system (Jackson-Rees modification of Ayer's T-piece) with a mixture of sevoflurane 8 vol % in 100% O2 (6 L/min). After loss of consciousness, intravenous line will be inserted and Rocuronium 0.6 mg/kg is administered and when adequate depth of anesthesia is reached, a laryngeal mask airway (LMA) of appropriate size for the age and weight of the child will be placed .Anesthesia will maintained with sevoflurane at 2 3 vol % in 40% O2 in air to maintain a stable heart rate, blood pressure and respiratory rate (base line ± 20%). Paracetamol 15 mg/kg (Perfalgan® 100 ml vial UPSA France) and Dexamethasone 0.3 mg/kg will be administered IV to each child immediately after the induction of anesthesia. Lung ventilation will be controlled to maintain the end tidal carbon dioxide tension between 30 and 35 mmHg. Caudal block with 1.0 ml/kg 0.25% bupivacaine will be performed in all patients. Failure of caudal block will be defined as increase in heart rate and or mean arterial blood pressure (MAP) > 10% than pre-incisional value at the start of surgery. No opioid will be given; no propofol will be used during the procedure.
The allocated children will be randomly assigned through computer-generated random numbers contained in sealed opaque envelopes to one of the three groups:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nalbuphine | Experimental | Drug: Nalbuphine0.1 mg/kg nalbuphine diluted in 10 ml I.V 10 minutes before the end of surgery |
| dexmedetomedine | Experimental | Drug: Dexmedetomidinereceive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery |
| saline | Placebo comparator | Drug: normal Salinereceive a saline solution 10 min before the end of surgery |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status I \&II
- scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) under general anesthesia
Key exclusion criteria (9 listed)
- history of hypersensitivity to the studied drug,
- refusal of the legal guardian
- chronic or acute intake of any sedative or analgesic drugs,
- Psychological\& emotional disorder.
- Cognitive or developmental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NalbuphineAlso: nalophenwill receive 0.1 mg/kg NAL diluted in 10 ml I.V 10 minutes before the end of surgery | Drug | nalbuphine |
| DexmedetomidineAlso: Precedexwill receive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery | Drug | dexmedetomedine |
| normal SalineAlso: salinewill receive with a saline solution 10 min before the end of surgery | Drug | saline |
Primary outcome
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) change
Time frame: at 5, 10, 20 and 30 minutes post-operatively
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) based on crying, facial expression, verbal statements, position of torso, touching of the wound and movement of legs will be used for post-operative pain assessment * minimum score: 4 best * maximum score: 13 worse
pediatric anesthesia emergence delirium (PAED) scale change
Time frame: at 5, 10, 20 and 30 minutes post-operatively
pediatric anesthesia emergence delirium (PAED) scale, scale that define the child's behavior in the recovery room 1. sleeping (best) 2. awake, calm 3. irritable, crying 4. inconsolable crying (worse)
1 secondary outcome
The time of first postoperative analgesic dose
Time frame: up to 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yasser M osman principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine, Dexmedetomidine and normal Saline in people with Agitation, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasser M osman (+201006357996, yasseralx@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) change (time frame: at 5, 10, 20 and 30 minutes post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.